A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Immunogenicity of AV-1959R in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Safety and Tolerability of AV-1959R Compared to Placebo
研究概览
简要总结
This Phase 1 clinical trial evaluates the safety, tolerability, and immune response of the adjuvanted AV-1959R vaccine in healthy adults aged 40-60. Participants will receive three intramuscular injections of either adjuvanted AV-1959R (100 µg or 300 µg) or adjuvanted placebo at Weeks 0, 4, and 14, followed by an 8-week follow-up. Researchers will monitor for side effects and measure anti-Aβ antibody levels to assess immune response. This study will help determine if AV-1959R is safe and effective in generating a targeted immune response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female adults, 40-60 years old.
- •BMI 18.0-32.0 kg/m².
- •No significant medical conditions or abnormal MRI, ECG, or lab tests.
- •Signed informed consent and ability to follow study procedures.
- •Females must be postmenopausal or surgically sterile.
- •Males must use contraception or be vasectomized.
排除标准
- •History of Alzheimer's, stroke, or neurodegenerative disease.
- •MRI abnormalities, such as infarcts or microbleeds.
- •Serious illness, surgery, or hospitalization in the last 4 weeks.
- •Significant heart, lung, liver, kidney, or immune disorders.
- •Recent drug/alcohol abuse or severe allergies.
- •Abnormal lab tests (e.g., high liver enzymes, kidney dysfunction, HIV, Hepatitis B/C positive).
- •Use of investigational drugs or amyloid/tau therapies in the last year.
- •Chronic use of immunosuppressants, anticoagulants, or blood products.
- •Pregnant, breastfeeding, or women of childbearing potential.
- •Recent blood donation (>400 mL) in the last 30 days.
研究组 & 干预措施
Arm 1: AV-1959R (100 µg) + Adjuvant - Cohort 1
Participants receive 100 µg of AV-1959R with the adjuvant via intramuscular injection
干预措施: AV-1959R (Abeta vaccine) (Biological)
Arm 2: Placebo (Adjuvant Only) - Cohort 1
Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection
干预措施: AV-1959R (Abeta vaccine) (Biological)
Arm 3: AV-1959R (300 µg) + Adjuvant - Cohort 2
Participants receive 300 µg of AV-1959R with the adjuvant via intramuscular injection
干预措施: AV-1959R (Abeta vaccine) (Biological)
Arm 4: Placebo (Adjuvant Only) - Cohort 2
Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection
干预措施: AV-1959R (Abeta vaccine) (Biological)
结局指标
主要结局
Safety and Tolerability of AV-1959R Compared to Placebo
时间窗: Up to 26 weeks
Safety will be assessed by the incidence of AEs and SAEs after intramuscular administration of AV-1959R (100 mcg and 300 mcg) or placebo through Week 26. Injection site reactions, clinical laboratory results, vital signs, physical examinations, and MRI will also be monitored through Week 26.
次要结局
- Participants With an Anti-Aβ Antibody Response(Day 42 (after two immunizations))
- Immunogenicity of AV-1959R: Anti-Aβ Antibody Response(Day 42 (after two immunizations))